BEUDAMED
    FDA Enforcement Class II Ongoing

    Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL

    Recall: Z-1608-2023 · Reported May 24, 2023

    Enforcement

    Recall Number
    Z-1608-2023
    Event ID
    92071
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2023
    Initiation Date
    April 5, 2023
    Classification Date
    May 18, 2023
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL

    Reason

    There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

    Code Info

    All Lots: UDI-GI: 15099590060206

    Distribution

    Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Guam, & Puerto Rico and OUS (foreign) countries of: Brazil ,Canada, Mexico, Panama, Taiwan,

    Quantity

    48,633 units in total